Overview

On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tofidence, intended for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and coronavirus disease 2019 (COVID-19).

The applicant for this medicinal product is Biogen Netherlands B.V.

Tofidence will be available as 20 mg/ml concentrate for solution for infusion. The active substance of Tofidence is tocilizumab, an interleukin inhibitor (ATC code: L04AC07). Tocilizumab is a recombinant humanised anti-human interleukin-6 receptor (IL-6R) monoclonal antibody of the immunoglobulin IgG1 subclass. It works by inhibiting soluble and membrane-bound interleukin‑6 receptors implicated in the pathogenesis of inflammatory diseases.

Tofidence is a biosimilar medicinal product. It is highly similar to the reference product RoActemra (tocilizumab), which was authorised in the EU on 16 January 2009. Data show that Tofidence has comparable quality, safety and efficacy to RoActemra. More information on biosimilar medicines can be found here.

The full indication is:

Tofidence, in combination with methotrexate (MTX), is indicated for:

  • the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
  • the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease- modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, Tofidence can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tofidence has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Tofidence is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Tofidence is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tocilizumab can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Tocilizumab in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, COVID-19, pJIA or sJIA. All patients treated with tocilizumab should be given the patient alert card.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Tofidence

AdoptedReference Number: EMA/CHMP/134201/2024

English (EN) (111.09 KB - PDF)

First published:
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Product details

Name of medicine
Tofidence
Active substance
tocilizumab
International non-proprietary name (INN) or common name
tocilizumab
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • COVID-19 virus infection
  • Arthritis, Juvenile Rheumatoid
  • Cytokine Release Syndrome
  • Giant Cell Arteritis
Anatomical therapeutic chemical (ATC) code
L04AC07
EMA product number
EMEA/H/C/005984
Marketing authorisation applicant
Biogen Netherlands B.V.
Opinion adopted
25/04/2024
Opinion status
Positive
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